BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 9249190 · Received October 29, 2019

    Report

    Report Number
    3002808486-2019-01761
    Event Type
    Death
    Date Received
    October 29, 2019
    Date of Event
    January 15, 2018
    Report Date
    October 29, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) K172557. SUMMARY OF INVESTIGATIONAL FINDINGS: THE REPORTED ALLEGATIONS HAVE BEEN INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. NEW PE AS A REPORTED COMPLICATION, IS A KNOWN RISK IN RELATION TO FILTER IMPLANT AND IS WELL DOCUMENTED IN THE CLINICAL LITERATURE AND IN CLINICAL PRACTICE GUIDELINES. THIS IS SUPPORTED BY THE CLINICAL EVIDENCE REPORT ESTABLISHED TO ASSESS AVAILABLE CLINICAL DATA TO IDENTIFY AND EVALUATE THE CLINICAL SAFETY AND PERFORMANCE OF THE COOK VENA CAVA FILTERS. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: PULMONARY EMBOLISM. IVC OCCLUSION/ THROMBOSIS, NEW DVT, IVC STENOSIS AS A REPORTED COMPLICATION, IS A KNOWN RISK IN RELATION TO FILTER IMPLANT AND IS WELL DOCUMENTED IN THE CLINICAL LITERATURE AND IN CLINICAL PRACTICE GUIDELINES. THIS IS SUPPORTED BY THE CLINICAL EVIDENCE REPORT ESTABLISHED TO ASSESS AVAILABLE CLINICAL DATA TO IDENTIFY AND EVALUATE THE CLINICAL SAFETY AND PERFORMANCE OF THE COOK VENA CAVA FILTERS. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: VENA CAVA OCCLUSION OR THROMBOSIS, VENA CAVA STENOSIS, DEEP VEIN THROMBOSIS. UNKNOWN IF THE REPORTED DEATH IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: 'IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2015. ALLEGED DEATH, PE AND DVT." PATIENT ALLEGEDLY RECEIVED AN IMPLANT VIA RIGHT COMMON FEMORAL VEIN DUE TO HISTORY OF PE/DVT NOT A CANDIDATE FOR ANTICOAGULATION DUE TO RECENT SURGERY (PER THE IMPLANT OPERATIVE REPORT). ON (B)(6) 2015, IVC FILTER PLACEMENT OPERATIVE REPORT: DIGITAL IMAGE AT THE CONCLUSION DISPLAYS THE FILTER IN GOOD ALIGNMENT WITH THE APEX AT THE SUPERIOR ASPECT OF L2.¿ PER CERTIFICATE OF DEATH, DATED (B)(6) 2018, IMMEDIATE CAUSE OF DEATH IS PULMONARY EMBOLISM CONTRIBUTED BY DEEP VEIN THROMBOSIS, ACUTE KIDNEY INJURY AND HYPERTENSION. PATIENT OUTCOME: PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045181 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death